The MEB Portal offers applicants for marketing authorisations and marketing authorisation holders online access to information about the status of procedures.
Please note: since the MEB Citrix systems have been switched off due to the recent safety warnings, the MEB portal is not available at the moment. Read the news item for more information.
The portal offers the marketing authorisation holder the following information of its own medicinal products:
- An overview of open and/or recently closed submissions of applications and changes (variations)
- A detailed overview per submission, including data on the phase the process is in, the MEB employee/case manager currently handling the submission and data on the medicinal products that are linked to the submission.
User management has largely been outsourced to the relevant marketing authorisation holders. Using the so-called CBG Identity Management System, a single person within the organisation (the company administrator) is given access and administration rights to grant other users access. The MEB plays a supporting role in this process.
A great deal of attention has been paid to securing the information displayed.
Obtaining initial access to the portal
In order to gain access to the MEB Portal, please send the completed and signed application form to the MEB together with the requested annexes. The application form must be signed by the same person listed in the Chamber of Commerce registry. A copy of a recent excerpt from the Chamber of Commerce registry (no older than 6 months) must be enclosed.
Please consult the related application instructions for help filling out the application form.
The portal administrators will subsequently create a group for the marketing authorisation holder with the organisations linked as requested. They will then send a letter to the applicant with a temporary access code for the portal.
Once the MEB receives the required information, a single person within your organisation is given the authorisation to create and manage other user accounts in the Identity Management System.
Adding other organisations to the group account
Multiple, closely allied marketing authorisation holders can be treated as a single organisation in the portal. This allows you to view all submission data for all related organisations - mother, daughter or sister – in a single overview within the portal.
Mutual approval is required from all involved organisations/legal entities. In order to allow this, you must complete the relevant application form for each of the organisations you wish to add. You can fill out the application forms for the multiple, closely allied marketing authorisation holders together and submit these to the MEB.
Please consult the related application instructions for help in filling out the application form.
Portal managers can be contacted at Portal@cbg-meb.nl, or via Tel. +31 88 2248400.
MEB Portal maintenance
Due to scheduled maintenance, the MEB Portal is unavailable on Thursdays from 19.00 - 22.00 CET.